Prescription compliance device and method of using device

ABSTRACT

A prescription compliance device which aids patients in complying with instructions given by a physician for taking prescription medication. The device reminds a patient when the next dose of medication is to he taken and indicates whether a specified dose has been taken. The device includes a microcontroller, a display, a program memory for storing pre-programmed medication-taking regimens for single and multiple medications, a real time clock, a selector for selecting one of the regimens and for programming the device as to the time and day on which a first dose of medication is to be taken, a display which alternately displays the current time and a time at which a next dose of medication is to be taken, and an alarm which alerts the patient at times when a dose of medication is to be taken. The selector includes an event switch which is activated by the patient after taking a dose of medication so as to record the taking of the medication and to cause the microcontroller to effect the display of the next time at which a dose of medication is to be taken. A memory may also be included to record the times at which a patient takes doses of medication. The device is small enough to be attached to medication containers, and includes a remote programming feature via a wireless link.

CROSS-REFERENCES TO RELATED APPLICATIONS

This is a Continuation-in-Part application of the InternationalApplication Ser. No. PCT/US96/09241 filed Jun. 14, 1996 which isincorporated herein by reference. In addition, fuill benefit of thefiling date of U.S. Provisional Application Ser. No. 60/000,232 filedJun. 15, 1995, International Application Ser. No. PCT/US96/09241 filedJun. 14, 1996, and U.S. Provisional Application Ser. No. 60/044,265filed Apr. 25, 1997 are claimed pursuant to the provisions of 35 U.S.C.§119(e), and are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to an apparatus which aids patients in complyingwith instructions given by a physician for taking prescriptionmedication, and more particularly, to a device which is programmable inaccordance with the physician's instructions or desired regimen.

2. Discussion of the Background Art

A variety of devices have been proposed for recording intervals at whichpatients, especially those under the care of an attendant, takemedication at periodic intervals prescribed by a physician. If thepatient or his medical care provider ignores the proper instructions andrepeats the dose too frequently or fails to administer or takemedication at the proper time, the concentration of medication in thepatient's body may become too high or too low. In order to ensure thatmedications are taken at the proper time, a variety of devices, such asthe one disclosed in U.S. Pat. No. 4,361,408, have been devised togenerate audible and/or visible prompting or alarm signals that remind apatient or his caretaker to administer the correct dosages at thecorrect time. Such devices have been complex and costly, inconvenient toprogram, and have not been flexible enough in establishing varying timeintervals at which the medication needs to be administered.

SUMMARY OF THE INVENTION

Accordingly, one object of this invention is to provide a low cost, easyto use prescription compliance device that has the flexibility ofoperating in accordance with various different medication-takingintervals.

Another object of this invention is to provide a prescription compliancedevice which is easily programmable either by activating a programmer onthe device itself or by remotely programming the device via a wirelesslink. Multiple programming regimens which correspond to differentmedication-taking intervals and medication-types may also be programmedinto the device.

Yet another object of this invention is to provide a prescriptioncompliance device which records the event of taking a dose of medicationand displays the time at which the next dose of medication is to betaken.

A still further object of this invention is to provide a prescriptioncompliance device having a timer which measures the time that haselapsed since the patient last took a dose of the medication and analarm which is activated at times when the patient is to take the nextdose of medication.

A further object of this invention is to provide a prescriptioncompliance device that maintains a count of the number of dosesremaining in a patient's prescription and displays the count so that apatient will know when to have the prescription refilled.

Another object of this invention is to provide a prescription compliancedevice that alerts a patient when the patient has missed a scheduleddose of medication or has taken a dose of medication at a non-scheduledtime.

Yet another object of this invention is to provide a prescriptioncompliance device which records the times at which a patient takes eachdose of medication in a format that can be easily accessed via awireless interface.

These and other objects are accomplished by a prescription compliancedevice which includes a microcontroller, a program memory which storesdata representing a plurality of pre-programmed medication-takingregimens for single and multiple medications, an oscillator whichcontrols timing functions of the device, a selector selecting one of theregimens and programming the device in accordance with the selectedregimen, a display which alternately displays the current time, the timeat which a next dose of medication is to be taken in accordance with theregimen selected by the selector, and the number of doses remaining in aprescription, and an alarm which alerts the patient at times when thepatient is scheduled to take a dose of medication. The device may alsoinclude a memory which records the times at which a patient takes eachdose of medication in a format that can be easily accessed via awireless interface.

The selector includes an event switch which is activated by the patientafter taking a dose of medication to record the taking of themedication, the event switch causing the microcontroller to effect thedisplay of the next time at which a dose of the medication is scheduledto be taken, in accordance with the regimen selected by the selector.

The event switch and a function button are provided for programming theregimens by which the medication is to be taken, the day of the week onwhich the first dose is to be taken, the time at which the first dose isto be taken or the designation of meals during which the first dose isto be taken, and the number of doses in a patient's prescription.

Programming may be done either directly by using the function button andthe event switch or remotely via a wireless link. To program from aremote location, the device is provided with a wirelesstransmitter/receiver and an external wireless transmitter/receiverconfigured to be connected to an input device. The external wirelesstransmitter/receiver communicates with the wireless transmitter/receivervia a wireless link to select one of the regimens and to program thedevice in accordance with the selected regimen.

The display includes a first display area which displays a number of theregimen selected by the selector, a second display area which mayalternately display the current day of the week and a day of the week onwhich a next dose of medication is to be taken, a third display areawhich alternately displays the current time, the time or meal at whichthe next dose of medication is to be taken, and the number of dosesremaining in a prescription, a fourth display area which alternatelydisplays AM or PM designations for the current time and the time atwhich a next dose of medication is to be taken, and a fifth display areawhich displays an icon indicating the nature of the informationcurrently displayed in the first through fourth display areas.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the invention and many of the attendantadvantages thereof will be readily obtained as the same becomes betterunderstood by reference to the following detailed description whenconsidered in connection with the accompanying drawings, wherein:

FIG. 1 is an illustration of a prescription compliance device inaccordance with a first embodiment of the present invention;

FIG. 2 is a block diagram of a prescription compliance device of FIG. 1;

FIGS. 3A-3E are flow diagrams illustrating the steps followed whenoperating the prescription compliance device;

FIG. 4 is a table listing examples of common medication-taking regimenswhich may be programmed into the prescription compliance device;

FIG. 5 is an illustration of a prescription compliance device inaccordance with a second embodiment of the present invention;

FIG. 6A is a flow diagram illustrating the menu choices available to theuser;

FIGS. 6B-6H are flow diagrams illustrating the steps followed whenoperating the menu options shown in FIG. 6A;

FIG. 7 is a block diagram of a prescription compliance device includinga memory for recording the takings of medication and wirelessprogramming capabilities;

FIG. 8A illustrates the prescription compliance device according to thepresent invention as a free standing device;

FIG. 8B illustrates a top view of the prescription compliance device andattachment mechanism according to the present invention;

FIG. 8C illustrates a cross-sectional view of the prescriptioncompliance device attached to a bottle according to the presentinvention; and

FIG. 9 is another table listing examples of common medication-takenregimens which may be programmed into the prescription compliancedevice.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, wherein like reference numerals designateidentical or corresponding parts throughout the several views, and moreparticularly to FIG. 1 thereof, a prescription compliance device 1according to a first embodiment of the present invention includes afunction button 2a, a reset button 2b, and an event switch 4 forprogramming the device, and a display 3 for displaying the programmedinformation. The event switch 4 is activated by the patient upon thetaking of a dose of medication.

Prescription Compliance Device For Single Medications

FIG. 2 illustrates a block diagram of the prescription compliance deviceaccording to the first embodiment of the invention. The illustrated anddescribed configuration is exemplary and any desired hardwareimplementation can be used. An 8-bit microcontroller 9 such as MicrochipPart No. PIC 16C954, for example, which controls the overall functionsof the device includes a program memory 20 for storing preprogrammedmedication-taking regimens. A 32 KHz crystal oscillator 7 controls alltimings of the device. The program memory 20 is preferably a dedicatedchip mask read only memory (ROM), although other nonvolatile memoriessuch as a flash memory or EEPROM may be used. The specific parameters ofthe microcontroller, program memory, and the oscillator are set forthhere solely for illustrative purposes and are not intended to limit thescope of the invention. The use of equivalent elements is contemplatedwithin the scope of this invention.

The microcontroller receives inputs from the function and reset buttons2a, 2b and from the event switch 4 and controls the device functions inaccordance with the pre-programmed regimens stored in program memory 20.The microcontroller 9 is connected via an 8-bit bus 21 to display driver11 which drives the display 3 to display relevant information in displayareas 31-35. The display 3 is preferably a liquid crystal display (LCD)and the display driver 11 an ASIC LCD driver. Battery 12 is preferably a3 volt battery and alarm circuit 8 may visually and/or audibly promptthe patient to take medication. However, equivalents are also within thescope of the invention.

The operation of the prescription compliance device according to thisembodiment of this invention will now be described with reference toFIGS. 3A-3E. Patients who are under the care of an attendant areinstructed to take medication at periodic intervals as prescribed by aphysician. Upon receiving the prescription, the patient or his medicalcare provider employs the prescription compliance device to aid thepatient in complying with the instructions given by the physician.

First, the device must be switched from an OFF state to an ON state bypressing the reset button (Step S1). A "SET" icon is displayed indisplay area 35 to indicate that the device is in a setup mode. Thepatient first sets the current time (Steps S2 and S3) as follows.

The event switch 4 is pressed and the microcontroller 9 directs thedisplay area 33 to blink hour digits "12". Hours "1" through "12" arescanned through by pressing the event switch 4 and the appropriate houris selected by pressing the function button 2a when that hour isdisplayed.

The minutes tenth digit then blinks "0" and the digits "0" through "5"are scanned through by pressing the event switch 4. The appropriatedigit is selected by pressing the function button 2a when that digit isdisplayed.

The minutes unit digit then blinks "0" and the digits "0" through "9",are scanned through by pressing the event switch 4. The appropriatedigit is selected by pressing the function button 2a when that digit isdisplayed.

The display area 34 then blinks "A" and the patient selects AM or PMtime designations using the event switch 4 to toggle between the two andthe function button 2a to select. This completes the setting of thecurrent time.

The patient now selects the regimen by which the prescription medicationis to be taken. Upon depressing the event switch 4, the display area 35displays "RGMN" and the display area 31 blinks "0", prompting thepatient to scan through and select a desired regimen using the eventswitch 4 (Step S4). FIG. 4 lists examples of common programming regimenswhich may be pre-programmed into program memory 20. These regimens arelisted only by way of example and other regimens are possible.

In FIG. 4, regimens are provided for taking the medication 1, 2, 3, 4,or 6 times daily, taking the medication with breakfast and dinner, withbreakfast, lunch, and dinner, or with breakfast, lunch, dinner, and atbedtime, and for taking the medication once every 48 hours.

The patient presses the event switch 4 to advance through theprogramming regimens. During scanning, regimen numbers appear in displayarea 31 and descriptions of the regimens appear in display area 35 sothat the patient knows which regimen each number corresponds to. Forexample, when "8" appears in display area 31, "3:D" appears in displayarea 35 to indicate to the patient that programming regimen 8corresponds to taking medication three times daily.

When the desired regimen is displayed, the function key 2a is pressed(Step S5) and the display 3 prompts the patient to choose betweenstandard, pre-programmed default times corresponding to the selectedregimen or setting a specific time at which the first dose is to betaken. If the default times for taking the medication are acceptable,the patient presses the event switch 4 and is then prompted to enter thenumber of doses in the prescription (Step S21).

If the patient instead wants to set the time at which the first dose isto be taken, the microcontroller 9 directs the display area 33 to blinkhour digits "12". Unless the patient selects one of the meal regimens,the time of day at which the first dose of the medication is to be takenis next programmed (Steps S6 and S7). Hours "1" through "12" are scannedthrough by pressing the event switch 4 and the appropriate hour isselected by pressing the function button 2a when that hour is displayed.

The minutes tenth digit then blinks "0" and the digits "0" through "5"are scanned through by pressing the event switch 4. The appropriatedigit is selected by pressing the function button 2a when that digit isdisplayed.

The minutes unit digit then blinks "0" and the digits "0" through "9"are scanned through by pressing the event switch 4. The appropriatedigit is selected by pressing the function button 2a when that digit isdisplayed.

The display area 34 then blinks "A" and the patient selects AM or PMtime designations using the event switch 4 to toggle between the two andthe function button 2a to select. This completes the setting of the timeat which a first dose of medication is to be taken by the patient.

If one of the meal regimens is selected, the medication is to be takenwith meals the times of which will vary from person to person. Theprogram memory 20 has pre-programmed therein standard meal times(breakfast, lunch, dinner) during which most persons normally eat.However, the device is flexible enough to allow for different mealtimes, as will now be explained.

After a meal regimen is selected, display area 33 blinks "D" for defaultmeal times. If the patient eats meals at the standard times programmedinto the program memory 20, then the function button 2a is pressed when"D" is displayed (Step S8). If the patient eats at different times, thenpressing the event switch 4 (Step S9) allows the patient to togglebetween "D" and "S" (indicating `set`). Pressing the function key 2awhen "S" is displayed (Step S10) allows the user to set his breakfast,lunch, dinner, and bedtimes as follows. After the function key 2a ispressed, "BRKF" appears in display area 35 and "12" blinks in displayarea 33. The patient's breakfast time (hour, minute, AM/PM) is enteredas described above (Steps S11 and S12).

After programming the breakfast time, the operation varies according tothe specific regimen selected. For explanatory purposes, regimens 1, 2,and 3 refer to the meal designations listed in FIG. 4. If regimen 2 or 3has been selected, "LNCH" appears in display area 35 and the timesetting process is repeated to set the patient's lunch time (Steps S13and S14). "DINR" then appears in display area 35 under regimens 1, 2,and 3 and the patient's dinner time is similarly set (Steps S15 andS16). Finally, "BDTM" appears in display area 35 if regimen 3 isselected and the patient's bedtime is set as described above (Steps S17and S18).

Once the time/meal designations have been programmed, the display area32 then blinks "SU", prompting the patient to program the day of theweek on which the first dose is to be taken. The days "SU" through "SA"are scanned through by pressing the event switch 4 (Step S19) and theappropriate day is selected by pressing the function button 2a (StepS20).

The display area 35 then displays "CNT," prompting the patient to enterthe number of doses in the current prescription. Display area 33 blinks"0" and the patient scans up using the event switch 4 until the desirednumber is displayed (Step S21). The function button 2a is then pressedto select this number (Step S22).

The display area 35 then prompts the patient to enter the number of daysthat the current prescription is scheduled to last. Display area 33blinks "0" and the patient can scan up using the event switch 4 untilthe desired number is displayed (Step S23). The function button 2a isthen pressed to select this number (Step S24).

This completes the setup process. Display area 35 next displays "STRT"and display area 33 displays a question mark ("?"). When the userpresses the event switch 4, the device is in an operation mode (StepS25). The operation mode is defined as a mode the device resides inafter the user has programmed the desired options. Display 3 mayalternately display the current time or the time at which the next doseis to be taken. When the current time is displayed, display area 35displays "TIME," display area 31 displays the number of the regimenselected by the patient, display areas 33 and 34 display the currenttime of day, and display area 32 displays the current day of the week.When the time of taking the next dose of medication is displayed,display areas 33 and 34 display the time at which the next dose is to betaken, display area 32 displays the day of the week on which the nextdose is to be taken, display area 31 continues to display the number ofthe selected regimen, and display area 35 displays "NEXT."

After the device is programmed and the event switch 4 is pressed toenter the operation mode, the patient is aware of the day and time atwhich the first dose of the medication must be taken. At the time fortaking the first dose, the microcontroller 9 directs the alarm circuit 8to emit an audible and/or visible signal to alert the patient that thefirst dose must be taken at this time (Step S26). The alerting signalcontinues to be emitted intermittently until the patient takes the doseand presses the event switch 4 or until a prescribed time has elapsed(Step S27). During this time, display area 35 displays "TAKE" indicatingthat it is time to take the next dose. If the patient takes the dosemore than a prescribed time before the scheduled time and presses theevent switch 4, the alarm circuit 8 is activated (Step S28) and thedisplay area 35 indicates "ERR" (Step S29) to indicate that the patienthas not properly followed the selected regimen.

If the patient fails to take the dose within a prescribed time after thescheduled time while the alarm circuit 8 is activated, display area 35displays "MISS" (Step S34) indicating that the patient has missed takingthe scheduled dose. The display then indicates the time that the misseddose was scheduled to be taken (Step S35) and prompts the patient todirect the device as to how to proceed (Step S36). At this point thepatient may press the event switch 4 to maintain the current regimen(Step 37) or may select a new regimen (Step S38).

Upon taking the first dose, the patient presses the event switch 4 whichrecords the taking of the medication and causes the microcontroller toautomatically calculate the time/meal at which the next dose ofmedication must be taken according to the selected regimen and to effectthe display of this time on the display 3 (Step S39). Themicrocontroller also subtracts the dose taken from the total number ofdoses in the prescription to update the count of remaining doses. Thisnumber is displayed in display area 33 while "LEFT" is displayed indisplay area 35 to indicate the number of doses remaining (Step S40).

Likewise, at the end of each day the microcontroller subtracts one fromthe total number of days in the prescription to update the count ofremaining days. This number is displayed in display area 33 to indicatethe number of days remaining (Step S41).

These operating procedures are repeated for as long as the patient'sprescription is valid. When the number of doses in the prescription hasbeen nearly exhausted (i.e., six doses or less remaining), the displayindicates "FILL" and the alarm circuit is activated (Step S42). If thepatient has the prescription refilled at the direction of a physician,the operating procedures are resumed at Step S21. Otherwise, if thepatient has completed his prescription and needs no further medication,the device is turned off by pressing the reset button 2b (Step S43).

Prescription Compliance Device for Multiple Medications

FIG. 5 illustrates a block diagram prescription compliance deviceaccording to a second embodiment of the invention. In this embodiment,the user may program the device and monitor the status of multiplemedications.

In addition to the central processor and supporting circuitry shown inFIG. 2 for the first embodiment, the device 50 according to the secondembodiment includes a display 51 and a key pad 52. The display 51includes eight character and/or graphical display fields F1-F8 whichdisplay information to the user. This information could also bepresented using a dot matrix display and/or a scrolling display.Exemplary manners of implementing the display include using a liquidcrystal display (LCD), a cathode ray tube (CRT), or a plasma display.

Referring to FIG. 5, the field F1 informs the user if multiplemedications are to be taken, F2 informs the user of the specificprescription regimen being used with the medicine identified in F6 andF7, and F3 informs the user as to the status of the alarm or vibrator.When the device 50 is in an "OPERATE" mode, F4 informs the user whetheror not to take a medication. If the user is to take a medication, F4displays the word "TAKE," otherwise F4 displays the word "NEXT." An"OPERATE" mode is defined as a mode in which the device normally resideswithout an action on the part of the user. During a menu scan operation,the field F4 informs the user of the various options available. Thefield F4 also provides other information necessary to inform user of thenature or status of information that is being provided in the otherfields. The field F5 displays time information, such as the day of theweek, hour, minute, and AM or PM, and F6 is an optional character fieldidentifying a memory slot relating to a specific medication F7 displaysuser programmed information identifying a specific medication and F8advises the user if a program for a particular medication is operativeor if it has been suspended.

As shown in FIG. 5, the device 50 also includes a keypad 52 with sixkeys: SELECT 53, MENU 54, UP 55, DOWN 56, SNOOZE 57 and EVENT 58. Otherkeys such as a numeric keypad, an alpha-numeric key pad, or a computerkeyboard may be utilized, if desired. These keys are used duringprogramming and operation of the device. The UP 55 and DOWN 56 keysallow the user to scroll through the options under the various menuitems and the SELECT 53 key is used to select a desired option. Failureto activate the SELECT 53 key within a prescribed time interval returnsthe device to the OPERATE mode. Successive activation of the MENU 54 keycauses the field F4 to display the menu choices shown in FIG. 6A.Pressing the SELECT 53 key while one of these options is displayed setsthe device into the specific operation mode selected. The keypad 52 maybe combined with the display 51, as illustrated in FIG. 5, oralternatively the keypad 52 may be separate from the display 51.

The multi-medicine prescription compliance device also includes a SNOOZEswitch 57 and an EVENT switch 58. For the medication that is displayedin the fields F6 and F7, pressing the EVENT switch 58 causes thefollowing events to occur. When the field F4 displays the word TAKE, thecurrent date, time, and medication name is recorded, thus signifying themedication was taken. Then the field F4 displays the word NEXT and thenext time to take the medication is displayed in the field F5. However,if other medications have earlier take times, the field F4 displays theappropriate NEXT or TAKE screen for that medication. When the field F4displays the word NEXT and the time to take the medication is within apredetermined time range, the same sequence applies as when the F4displays the word TAKE. However, when the field F4 displays the wordNEXT and the time to take the medication has exceeded the predeterminedtime range, the current clock time and day are identified with themedication and the event is recorded. If the user fails to take themedication within the predetermined time range, the device advances tothe appropriate next take time for that medication. In addition, theSNOOZE button 57 is used to silence the alarm. The alarm will then skipone interval before alerting the user again.

The operation of the prescription compliance device according to thesecond embodiment of this invention will now be described with referenceto FIGS. 6A-6H. FIG. 6A illustrates the choices available to the userwhich can be scrolled through by pressing the MENU 54 key.

The menu choices shown in FIG. 6A include the options of TIME (StepS50), VIEW (Step S60), MEDICATION (Step S70), ALARM (Step S80), LOCK(Step S90), HELLO (Step S100) and RUN (Step S110) which are explainedbelow with respect to FIGS. 6B to 6H. The user scrolls through theoptions by pressing the MENU 54 key and then selects the desired optionwith the SELECT 53 key.

FIG. 6B illustrates the programming steps required to display or editthe current time. After the TIME option is selected (Step S50) in FIG.6A, the user has a choice to display the current time or edit thecurrent time (Step S51). If the user chooses to display the current timein Step S51 and executes the RUN option (Step S53), the current timewill be displayed in the field F6 (Step S54) and the device returns tothe OPERATE mode. If the user chooses to edit the current time in StepS51, the user scrolls through the times (days, hours, minutes) andselects a desired time (Step S52). After executing the RUN option (StepS53), the edited time will be displayed in the field F6 and the devicereturns to the OPERATE mode.

FIG. 6C illustrates the programming steps to view the differentmedications programmed into the device. After the VIEW option isselected (Step S60) in FIG. 6A, the user scrolls through the times thatvarious medications are to be taken (Step S61). The time the medicationis to be taken is displayed in the field F5 and the medicine identifiersare displayed in the fields F6 and F7. The user then selects the RUNoption (Step S62) to return the device to the OPERATE mode.

FIG. 6D illustrates the programming steps to view, omit or customize aspecific medication. After the MEDICATION option is selected (Step S70)in FIG. 6A, the user scrolls through and selects one of the variousmedications (Step S71). Upon selecting a medication, the user scrollsthrough and selects an option (Step S72) including "LAST", "FUTURE","OMIT" and "PROGRAM". The "LAST" option (Step S73) informs the user thelast time the medication was taken. The "FUTURE" option (Step S74)allows the user to scroll through the future times the medication is tobe taken and the "OMIT" option (Step S75) allows a user to temporarilyturn off the program for the selected medication. The ON/OFF status forthe medication is displayed in the field F8. The PROGRAM option (StepS76) allows the user to set (customize) program parameters for theselected medication. FIG. 6E illustrates the programming steps requiredto set the program parameters.

After the PROGRAM option is selected (Step S76) in FIG. 6D, the userenters customized information identifying the selected medication (StepS77a) in FIG. 6E. The customized information is displayed in the fieldF7. After Step S77a is performed, the user selects among several regimenoptions including a daily regimen (i.e., 1/Daily-once per day;2/Daily-twice a day; 3/Daily-three times a day, and 4/Daily-four times aday) (Step S77c), and an hourly regimen in which the user selects hourlyintervals to take the medication (Step 77d). Also included are aCYCLICAL (monthly cycle), MEAL (meal time), CUSTOMIZE (customized timeintervals), and RECORD (record time at which medication was taken)regimens. Upon selecting the CYCLICAL option, the user enters the numberof days in the cycle they take the medication (Step S77e). Then, theuser enters the days in the month (Step 77f), the start date in themonth that the user wants to start taking medication (Step 77g), and thecurrent date of the month (Step S77h). The user also enters the time thefirst dose is to be taken (Step 77m) for the DAILY, HOURLY, and CYCLICALregimens. After selecting the MEAL option, the user has a choice to takethe medication WITH, AFTER or BEFORE meals (Step S77j). After selectingthe CUSTOMIZE option, the user enters a specific time interval (StepS77k). The RECORD option (Step S77l) records the time the medication istaken. The user selects the RUN option (Step S77n) to return the deviceto the normal operating mode.

FIG. 6F illustrates the programming steps to program the ALARM options.After the ALARM option (Step S80) is selected in FIG. 6A, the userselects a low, high or vibrator ALARM (Step S81). The user then selectsthe RUN option (Step S82) to return the device to the normal operatingmode.

FIG. 6G illustrates the programming steps required to program the LOCKoption. After the LOCK option (Step S90) is selected in FIG. 6A, theuser has the choice to lock or unlock the programming features of thedevice (Step S91). If the user wants to lock the programming features,the user enters a code in Step S93. The code may include any combinationof numeric or character values. If the user chooses to unlock theprogramming features, the user enters the code to unlock the device(Step S92). The user then selects the RUN option (Step S94) to return tothe device to the OPERATE mode.

FIG. 6H illustrates the programming steps required to program the HELLOoption. After the HELLO option is selected (S100) in FIG. 6A, the usermay enter phone and name information or meal time information (StepS101). If the user chooses to enter phone and name information, the userenters the desired phone and name information (Step S102) then has achoice to enter another name and phone number (Step S104). If the userdesires to enter another phone and name number (Yes in Step S104), theprogramming procedure returns to Step S102. If the user does not wish toenter any more phone and name numbers (No in Step S104), the userselects the RUN option (Step S105) and the device returns to the OPERATEmode. If the user chooses to enter meal time information in Step S101,the user enters the desired meal times for breakfast, lunch, and dinnerin Step S103. After the desired meal time information is entered, theuser selects the RUN option in Step S105 to return the device to theOPERATE mode.

Wireless Output

FIG. 7 illustrates a third embodiment of the present invention. Sincethe programming and operation of the prescription compliance deviceaccording to this embodiment are identical in most aspects to those ofthe first and second embodiments, a description of the identicalfeatures will be omitted. Referring to FIG. 7, the prescriptioncompliance device further includes a wireless transmitter/receiver 40(Microchip Part No. SFH485) which communicates with an external wirelesstransmitter/receiver 41 via a wireless link (not shown). The externalwireless transmitter/receiver 41 includes a wirelesstransmitter/receiver 42 and an interface 43 for connection to an inputdevice, such as a personal computer. The interface is preferably astandard RS-232 serial interface, and infrared technology is employed inthe preferred embodiment to transmit and receive information. Thepersonal computer runs software by which the device may be programmedvia the personal computer instead of directly programming using thefunction buttons. The above-described programmning procedures for thefirst and second embodiments are carried out in this embodiment on apersonal computer. Programming the device is thus made more convenientby simply inputting the above-described parameters (time, meals, numberof pills, etc.) via a personal computer keyboard.

The information input by the patient or his medical care provider via apersonal computer is transmitted by the wireless transmitter/receiver 42and received by the wireless transmitter/receiver 40 and processed justas if it were directly input via the buttons described for the first andsecond embodiments. The wireless transmitter/receiver 40 transmits backto the external device the current status of the device and theinformation displayed on the display 3,51.

The device of FIG. 7 also includes a non-volatile memory 10 whichrecords the taking of each dose of medication by the patient when theevent switch 4,58 is pressed. Information as to which doses have beentaken is accessible via the wireless link so that a physician canexamine the patient's compliance in taking the medication. Thenon-volatile memory 10 of the preferred embodiment is an 8 KB serialEEPROM (Microchip Part No. 24LC08B), however equivalent memories may beemployed without departing from the scope of this invention. Afterprogramming the device on a personal computer, the patient's operationof the device is identical to that described above for the first andsecond embodiments.

The wireless transmitter/receiver 40 preferably utilizes Amplitude ShiftKeying (ASK) modulation to transmit/receive infrared energy to/from theexternal wireless transrnitter/receiver. Infrared technology has beendisclosed merely for illustrative purposes and other wirelesstechnologies and modulation methods are contemplated to be within thescope of the invention.

In addition, each prescription compliance device has a uniqueidentification number assigned thereto and stored in its program memory20 for the purpose of identifying a particular device when programmingfrom a remote location.

With regard to programming the device, parameters such as the day, timeof day, and other parameters may be set in a global register, whereasmedication specific parameters are programmed within a unique register.An additional capacity may be included to allow the user to review theinformation programmed into the device for each of the registers and toreview any other pertinent information. This information may be reviewedat the level of the device itself and/or through the wireless computerinterface.

The activation of the event switch 4,58 will cause temporal data to bestored in a non-volatile memory. In addition, such temporal data willhave associated with it an identifying character so that a utilizationof a specific medication or therapy can be tracked.

In addition to or as an alternative to identifying the individualregisters by characters or symbols, the device may also provideuser-friendly information, such as information identifying the specificmedication associated with a register by name or description (i.e.yellow pill, water pill, etc.). Additionally, instructions may beprovided in conjunction with an alarm providing the user with usefulinformation (i.e. take with food; avoid milk, etc.). Both types of suchadditional information would be accessible to each register to recalland display at appropriate times in either voice or character formats asdiscussed below.

The wireless emissions of the device can also be used as transducing theelements to activate secondary apparatuses. Thus, the emission of awireless signal in conjunction with an alarm can be used as a signal toactivate secondary alarms. The secondary alarms can be used to alertindividuals who are hearing or vision impaired, to alert deliverysystems to dispense medication to individuals who are mentally orphysically handicapped, or to activate any of a variety of other typesof apparatuses.

Within institutional settings, emissions from the prescriptioncompliance device which are triggered by the alarm logic, may be used inconjunction with medication or therapy dispensing stations, orsimilarly, to alert staff that the time has arrived to provide aspecific medication or therapy to a patient. Thus, according to thepresent invention, scheduling and planning of therapy regimens in thepharmacy, by the physician, or by any other care provider, may beprogrammed into the prescription compliance device. In this embodiment,the device can perform a function of instructing staff to providemedication or therapy in a prescribed manner and/or at prescribed times.

In the present invention, this prescription compliance device isequipped with a capacity for wireless emissions that are output inconjunction with activation of the event switch or passively by openingthe medicine bottle, etc. The wireless emissions carry the unique unitspecific signature and can be collected by independent receivers.Therefore, collection of emission data can be used to evaluate andmonitor the appropriate dispensing of medication and therapy, and toprovide an alert/alarm condition if serious omission or error occurs(e.g., a medication was not dispensed properly).

Wireless emission output may also be used to effect concurrent signalemission by another apparatus or device. Concurrent wireless emission bythe prescription compliance device and other apparatuses could bereceived by an independent recorder in very close time sequences, thusallowing temporal and proximity relation of action and instruments to beestablished. For example, the activation of the "Event Switch" on aprescription compliance device would emit a signal that would becollected by the independent receiver and would also cause anappropriate patient identifying device to emit a signal. This signalwould also be collected by the receiver. Through correlation of thereceiver identity, prescription compliance device identity, and patientidentity, a data set can be generated establishing a relationshipbetween a specific action, a specific place, a specific medication, anda particular patient.

Attachments

FIGS. 8A, 8B and 8C illustrate the prescription compliance deviceattached to a variety of containers and surfaces that are either flat orcurved. FIG. 8A shows the prescription compliance device as a freestanding device which is housed in a plastic casing that has anaccommodation on the back surface to permit attachment to a chain orloop that facilitates use as a key chain or pendent (not shown). Thedevice fits into a collar (A in FIGS. 8B and 8C) that are flexible andcan bend to accommodate the shape of curved containers or flat surfaces.The "wings" and back surface of the collar are coated with adhesivewhich attaches the attachment appliance to the surface or container(FIG. 8C). In applications where a narrow construct is required, the"wings" may be clipped off at points D (in FIG. 8B) and attachment tothe surface can be achieved solely through the adhesive on the back ofthe collar C (in FIG. 8C)

Thus, the prescription compliance device according to this invention maybe attached to medication containers by adhesives, straps, velcro,mechanical attachment, integration as a component of the containeritself, or by any other manner of attachment. The device also operatesfreestanding, and need not be attached to a medication container.

The device can be utilized in conjunction with or as a part of a widearray of medicine delivery systems and free standing units. Freestanding units independent of the medical container include use as, oras a part of a clock, pendent, key chain or watch. Other free standingapplications include configurations similar to those used for beepers orcellular telephones or any other similar configuration that can easilybe carried by a person. In addition to attaching the device to themedicine container or integration as a part of the medicine container,the current invention describes prescription compliance devices that canbe used with or are a part of blister packaging, medicine cabinets, pillbox or any other container intended for distributing medication.Additionally, the device can be integrated with, or used in conjunctionwith a cabinet, cart or other similar apparatus that is used inconjunction with dispensing medicine or therapy in an institutionalsetting.

ALARMS

As discussed above, the device triggers circuits to alert the patientwhen to take a dose of medication. These alarm capabilities include, inaddition to audio and visual signals, tactile signaling, such as avibrator or comparable mode of signaling, voice signaling achievedthrough a recording or digital generation, and the use of a wirelessoutput as a transducing element to activate a triggering of secondarydevices (e.g., alarms, patient assistance equipment, etc.) or to alertmedical personnel or other personnel that some form of action should betaken (e.g., providing medication or therapy). The avenue via which theprescription compliance device communicates information to the userincludes tactile and visual and auditory signaling.

The use of tactile stimulation, such as the vibrator used in a pager, orsome similar stimulus will provide the user with a discrete signal thatcan alert the user without alerting others in his/her company. Operationof a tactile stimulation will occur in a manner analogous to thatdescribed for the visual and auditory stimuli.

The device according to the present invention also includes the use ofrecorded signaling to provide the user with identification and/orinstructional information. In order for prescription devices to achievethese capabilities, they may be equipped with a microphone, speaker andsolid state recording device. In the recording mode, the user canprovide vocal input regarding identification of medication and/or properusage. Utilization of user (or medical care provider) recordedinformation will occur per logic employed at the level of the device'smicroprocessor(s) and may incorporate prerecorded information inaddition to that recorded by the user. Thus, with the multi-medicinedevice described, the logic in a specific register may be used todictate playback of a recorded sequence such as "10 PM ; Take YellowPills; Take with food." Such a sequence may combine user recorded andprerecorded signaling to alert the user to therapy identification, thetime of utilization, special instructions, and any other parameters thatmight be appropriate. Such sequences are appropriately utilized withinspecific registers in multi-medication devices, thus providing the userwith the proper timing and practical advice for the correct use ofspecific medications.

In addition, a user initiated action may be required to initiate thedisplay of either visual or recorded identification and instructionalinformation. Thus, the prescription device may first emit an audio,visual or tactile stimulus, and then an action by the user will causethe device to display the appropriate audio and/or visual information.Display of such audio or visual information may be accomplished in amanner so as to preserve the privacy of the user in hearing or viewingsuch information (e.g., an ear phone).

DOSING SCHEDULES

TABLE 1 summarizes dosing time intervals for morning, midday, afternoon,etc. Normally a patient is awake for 14 hours and it is over thisinterval that a patient is most likely to take medication prescribed ina given day. The 14 day is divided into a series of time intervalsdesirable for the patient to take medication. Alternatively, the dosingtime intervals may correspond to meal times (e.g., with, before, andafter breakfast, lunch, etc.).

                  TABLE 1                                                         ______________________________________                                        DOSAGE TIME INCREMENT  TIME (example)                                         ______________________________________                                        1.sup.st (Morning)                                                                        0      hr      8    AM (first dose of day)                        2.sup.nd (Mid day)                                                                                hr          PM      12                                    3.sup.rd (Afternoon)                                                                              hr           PM      3                                    4.sup.th (Evening)                                                                                hr           PM      5                                    5.sup.th (Late evening)                                                                           hr  12       PM     10                                    6.sup.th (Bedtime)                                                                                hr           pm     10                                    ______________________________________                                    

FIG. 9 illustrates additional programming regimens which allow the userto easily adjust a mediation-taking regimen.

Utilization of the specific times generated in such a matrix as shown inTable 1 allows simple definition of appropriate times for the patient totake medication under the most common regimens identified in FIG. 9 asRegimens 1, 2, 3 and 4. Medications not prescribed by these straightforward regimens may be handled by additional regimens. Regimen 0 is afully custom regimen which allows the patient to define up to, forexample, 9 specific times in a day when medication is to be taken.Regimen 5 is designed for medications that must be taken at prescribedintervals and may accommodate intervals of up to 99 hours. Regimen 6operates to define a specific interval after taking a dose of medicationprior to which another dose should not be taken. Regimen 7 defines amonthly cycle for taking medication (i.e., the patient is advised whento and when not to take medication over the course of a month or othercycle). Regimen 8, 9, and 10 are for use with medications that are to betaken in conjunction with meals. These regimen may have default times of8:00 AM, 12:30 PM, and 6:00 PM, but the patient is able to set timesappropriate for his own schedule. Regimen 11 is a record only mode whereonly activation of the event button is recorded.

Programming the regimens shown in FIG. 9 is similar to the programmingsteps described in the first and second embodiments. Briefly, to programone of the regimens in FIG. 9, the user sets the current time of the dayand selects a desired regimen number. To program regimen 0, the timesfor T1-T9 are set. The chain of times may be terminated by setting 0:00.For Regimens 1-4, the time for the first dose to be taken is set and thetake times are automatically calculated as appropriate.

For Regimen 5, the time for the first dose to be taken and the desiredtime interval is set. The time interval may be set as any number between0 and 100 or it may be selected from the sequence1,2,3,4,6,8,12,24,36,48,60,72,84,96 hr. The take times are automaticallycalculated by adding the interval time to the first dose time or thepreviously calculated take time.

For Regimen 6, the time interval is set as any number between 0 and 100or it may be selected from the sequence1,2,3,4,6,8,12,24,36,48,60,72,84,96 hrs. The take times areautomatically calculated by adding the interval time to the time thefirst time or the previously calculated take time.

For Regimen 7, the time for the first dose to be taken is set. Then thedays on (i.e., the number of consecutive days in which the prescriptionshould be taken) is set. The days in the cycle (i.e., days in month ornumber of days), and the current date or number of days in the cycle isset. The starting date in the cycle is set and the take times areautomatically calculated. The device additionally advises the user onwhat days in the cycle medication should be taken. When the user entersthe first take time in a new cycle, the device will prompt the user toenter a new value for the day in the cycle. For example, assume the userwanted to take medication from the 16th to the 25th of each month andtoday is April 9th. In this case, Day ON=10, Days in Cycle=30, CurrentDate=9, and Starting Date=16.

For Regimen 8, the user scans and selects a default time for Breakfast(08:00 AM), Lunch (12:30 PM), and Dinner (6:00 PM) and additionally theuser has the ability to alter the default time.

For Regimen 9, the user scans and selects a default time for Breakfast(08:00 AM), Lunch (12:30 PM), and Dinner (6:00 PM) (and may alter thedefault time) and the take times are automatically calculated by adding2 hours to the selected meal times.

For Regimen 10, the user scans default times for Breakfast (08:00 AM),Lunch (12:30 PM), and Dinner (6:00 PM) (and may alter the default time)and the take times are automatically calculated by subtracting 1 hourfrom the selected meal times.

The event switch shown in the first and second embodiments should be ofa size such that activation by an elderly person would not be difficultwhile at the same time safeguarding against accidental activation. Thereset button is of a size such that activation thereof requires a thin,needle-shaped object so as to safeguard against the accidental turningoff of the device. Accidental depression of the function button isharmless since this button has no effect when the device is not in thesetup mode except to de-activate the alarm circuit.

Provision is also made for a low battery indication. After the passageof a certain number of days from when the battery was last replaced, thedisplay displays "BAT" to indicate that the battery should soon bereplaced.

Electronic Configuration and Programming Parameters

This invention may be conveniently implemented using a conventionalgeneral purpose digital computer or microprocessor programmed accordingto the teachings of the present specification, as will be apparent tothose skilled in the computer art. Appropriate software coding canreadily be prepared by skilled programmers based on the teachings of thepresent disclosure, as will be apparent to those skilled in the softwareart. The invention may also be implemented by the preparation ofapplication specific integrated circuits or by interconnecting anappropriate network of conventional component circuits, as will bereadily apparent to those skilled in the art.

The present invention includes a computer program product which is astorage medium including instructions which can be used to program acomputer to perform a process of the invention. The storage medium caninclude, but is not limited to, any type of disk including floppy disks,optical discs, CD-ROMs, and magneto-optical disks, ROMs, RAMs, EPROMs,EEPROMs, magnetic or optical cards, or any type of media suitable forstoring electronic instructions.

Obviously, numerous modifications and variations of the presentinvention are possible in light of the above teachings. The specificparameters mentioned in conjunction with the description of theinvention have been set forth solely for illustrative purposes and arenot limiting of the scope of the invention in any way. It is thereforeto be understood that within the scope of appended claims, the inventionmay be practiced otherwise than as specifically described herein.

What is claimed as new and is desired to be secured by Letters Patent ofthe United States is:
 1. A prescription compliance devicecomprising:microcontroller; a program memory storing data representing aplurality of pre-programmed commonly prescribed medication-takingregimens; a selector selecting one of said regimens and programming saiddevice in accordance therewith; and a display, said selector includingan event switch which is activated in conjunction with a patient takinga dose of a medication corresponding to a respective medication-takingregimen to record the taking of said medication, said event switchcausing said microcontroller to effect the display of the time at whicha next dose of medication is scheduled to be taken, in accordance withthe regimen selected by said selector, wherein at least one of theplurality of pre-programmed medication-taking regimens causescalculation of acceptable times during which said patient is scheduledto take said medication, and wherein the calculated times are based onthe following factors:1) a preferred time of day at which the patient isto take a first dose of the medication; 2) a regimen specificpredetermined interval of time between doses of the medication; and 3) aregimen specific predetermined time range during which it is medicallyacceptable for the patient to take the medication.
 2. The deviceaccording to claim 1, further comprising:an attaching mechanism forattaching said device to a medication container.
 3. The device accordingto claim 1, further comprising:a transmitter/receiver; and an externaltransmitter/receiver configured to be connected to an input device, saidexternal transmitter/receiver communicating with saidtransmitter/receiver via a wireless link to select one of said regimensand program said device in accordance therewith from remote locations.4. The device according to claim 3, wherein said input device is apersonal computer.
 5. The device according to claim 3, wherein saidwireless link is an infrared link.
 6. The device according to claim 1,further comprising an alarm circuit alerting said patient at times whensaid patient is scheduled to take a dose of medication.
 7. The deviceaccording to claim 1, wherein said event switch is activated to scanthrough regimen and programming options, and wherein said selectorfurther includes:a reset button rendering said device on and off; and afunction button selecting an appropriate regimen and programmingoptions.
 8. The device according to claim 7, wherein each of saidregimens dictates the times at which said medication is to be takendaily or events during which said medication is to be taken, and whereinsaid programming options include:a time of day at which the first doseof medication is to be taken or designation of default times inaccordance with a selected regimen; and a day of the week on which saidfirst dose is to be taken.
 9. A device according to claim 8, whereinsaid programming options further include:said patient's specified timesfor said events; and a number of doses in a prescription.
 10. A deviceaccording to claim 1, wherein said display comprises:a first displayarea displaying a number of the regimen selected by said selector; asecond display area displaying a day of the week on which a next dose ofsaid medication is to be taken; a third display area displaying the timeor event during which the next dose of said medication is to be taken; afourth display area displaying AM or PM designations for the time atwhich a next dose of said medication is to be taken; and a fifth displayarea displaying an icon indicating the nature of the informationcurrently displayed in said first through fourth display areas.
 11. Thedevice according to claim 10, wherein said third display area furtherdisplays the current time.
 12. The device according to claim 11, whereinsaid third display area further displays the number of doses remainingin a prescription.
 13. The device according to claim 1, wherein saiddisplay is a liquid crystal display.
 14. The device according to claim6, wherein said alarm circuit is activated if said patient takes a doseof said medication and presses said event switch more than apredetermined time before or after a time at which a next dose isscheduled to be taken.
 15. The device according to claim 1, wherein saidmicrocontroller causes said display to display a low battery indicationafter a predetermined number of days have elapsed.
 16. The deviceaccording to claim 6, wherein said alarm circuit alerts said patient byemitting an audible signal.
 17. The device according to claim 6, whereinsaid alarm circuit alerts said patient by emitting a visible signal. 18.The device according to claim 3, further comprising a non-volatilememory recording times at which said patient takes doses of medicationwhen said event switch is activated, contents of said memory beingaccessible via said wireless link.
 19. The device according to claim 18,wherein said non-volatile memory comprises an electrically erasableprogrammable read only memory (EEPROM).
 20. The device according toclaim 1, wherein at least one of said plurality of pre-programmedmedication-taking regimens corresponds to a plurality of medications.21. The device according to claim 20, wherein said event switch isfurther activated to view prescription information based on saidpre-programmed medication-taking regimens.
 22. The device according toclaim 20, further comprising an alarm circuit alerting said patient attimes when said patient is scheduled to take at least one of saidplurality of medications.
 23. The device according to claim 20, whereinprescription compliance information is generated based on said pluralityof pre-programmed medication-taking regimens and said prescriptioncompliance information is recorded.
 24. The device according to claim 1,further comprising an alarm circuit providing at least one of an audio,voice and vibration indication.
 25. The device according to claim 1,further comprising:a transmitter/receiver; and an externaltransmitter/receiver configured to be connected to a secondary device,said transmitter/receiver communication with said externaltransmitter/receiver via a wireless link to activate said secondarydevice to perform at least one of generating an alarm, dispensing saidmedication, and transmitting prescription information based on saidpre-programmed medication-taking regimens to at least a third device.26. A prescription compliance device comprising:control means; programmemory means for storing data representing a plurality of pre-programmedcommonly prescribed medication-taking regimens; select means forselecting one of said regimens and programming said device in accordancetherewith; and display means, said select means including an eventswitch which is activated in conjunction with a patient taking a dose ofa medication corresponding to a respective medication-taking regimen forrecording the taking of said medication, said event switch causing saidcontrol means to effect the display of the time at which a next dose ofmedication is scheduled to be taken, in accordance with the regimenselected by said select means, wherein at least one of the plurality ofpre-programmed medication-taking regimens causes calculation ofacceptable times during which said patient is scheduled to take saidmedication, and wherein the calculated times are based on the followingfactors:1) a preferred time of day at which the patient is to take afirst dose of the medication; 2) a regimen specific predeterminedinterval of time between doses of the medication; and 3) a regimenspecific predetermined time range during which it is medicallyacceptable for the patient to take the medication.
 27. The deviceaccording to claim 26, further comprising:attach means for attachingsaid device to a medication container.
 28. The device according to claim26, further comprising:transmitter/receiver means; and externaltransmitter/receiver means configured to be connected to an inputdevice, for communicating with said transmitter/receiver means via awireless link to select one of said regimens and program said device inaccordance therewith from remote locations.
 29. The device according toclaim 28, wherein said wireless link is an infrared link.
 30. The deviceaccording to claim 28, wherein said input device is a personal computer.31. The device according to claim 28, further comprising non-volatilememory means for recording times at which said patient takes doses ofsaid medication when said event switch is activated, contents of saidmemory means being accessible via said wireless link.
 32. The deviceaccording to claim 31, wherein said non-volatile memory means comprisesan electrically erasable programmable read only memory (EEPROM).
 33. Thedevice according to claim 26, wherein said event switch is activated toscan through regimen and programming options, and wherein said selectmeans further includes:a reset button for rendering said device on andoff; and a function button for selecting an appropriate regimen andprogramming options.
 34. The device according to claim 27, wherein eachof said regimens dictates the times at which said medication is to betaken daily or events during which said medication is to be taken, andwherein said programming options include:a time of day at which thefirst dose of medication is to be taken or designation of default timesin accordance with a selected regimen; and a day of the week on whichsaid first dose is to be taken.
 35. A device according to claim 34,wherein said programming options further include:said patient'sspecified times for said events; and a number of doses in aprescription.
 36. A device according to claim 26, wherein said displaymeans comprises:a first display area displaying a number of the regimenselected by said selector; a second display area displaying a day of theweek on which a next dose of said medication is to be taken; a thirddisplay area displaying the time or event during which the next dose ofsaid medication is to be taken; a fourth display area displaying thetime at which a next dose of said medication is to be taken; and a fifthdisplay area displaying an icon indicating the nature of the informationcurrently displayed in said first through fourth display areas.
 37. Thedevice according to claim 36, wherein said third display area furtherdisplays the current time.
 38. The device according to claim 37, whereinsaid third display area further displays the number of doses remainingin a prescription.
 39. The device according to claim 26, wherein saiddisplay means comprises a liquid crystal display.
 40. The deviceaccording to claim 26, further comprising alarm means for alerting saidpatient at times when said patient is scheduled to take a dose of saidmedication.
 41. The device according to claim 40, wherein said alarmmeans is activated if said patient takes a dose of said medication andpresses said event switch more than a predetermined time before or aftera time at which a next dose is scheduled to be taken.
 42. The deviceaccording to claim 26, wherein said control means causes said displaymeans to display a low battery indication after a predetermined numberof days have elapsed.
 43. The device according to claim 40, wherein saidalarm means alerts said patient by emitting an audible signal.
 44. Thedevice according to claim 40, wherein said alarm means alerts saidpatient by emitting a visible signal.
 45. A method of operating aprescription compliance device, comprising the steps of:(a) switchingsaid device to a setup state; (b) programming the current time into saiddevice; (c) selecting one of a plurality of pre-programmed commonlyprescribed medication-taking regimens; (d) programming a time of day afirst dose of medication is to be taken in accordance with the selectedregimen; (e) switching said device from a setup state to an operationstate; and (f) indicating to said device that a dose of medication hasbeen taken, wherein at least one of the plurality of pre-programmedmedication-taking regimens causes calculation of acceptable times duringwhich said patient is scheduled to take said medication, and wherein thecalculated times are based on the following factors:1) a preferred timeof day at which the patient is to take a first dose of the medication;2) a regimen specific predetermined interval of time between doses ofthe medication; and 3) a regimen specific predetermined time rangeduring which it is medically acceptable for the patient to take themedication.
 46. The method according to claim 45, further comprising thesteps of:(g) programming a day of the week on which said first dose ofmedication is to be taken; (h) programming a number of doses in aprescription; and (i) switching said device from an operation state toan off state after said prescription has been nearly exhausted.
 47. Themethod according to claim 45, wherein said step (b) is executed byactivating an event switch to scan through times as displayed on adisplay, and activating a function button to select the current timewhen displayed.
 48. The method according to claim 45, wherein said step(c) is executed by activating an event switch to scan through saidpre-programmed regimens as displayed on a display, and activating afunction button to select an appropriate regimen when displayed.
 49. Themethod according to claim 45, wherein said step (d) is executed byactivating an event switch to scan through times or events as displayedon a display, and activating a function button to select an appropriatetime or event when displayed, or activating an event switch to designatepre-programmed default times in accordance with a selected regimen. 50.The method according to claim 46, wherein said step (g) is executed byactivating an event switch to scan through days of the week as displayedon a display, and activating a function button to select an appropriateday when displayed.
 51. The method according to claim 46, wherein saidstep (h) is executed by activating an event switch to scan throughnumbers as displayed on a display, and activating a function button toselect an appropriate number when displayed.
 52. The method according toclaim 45, wherein said step (e) is executed by activating an eventswitch after one of said regimens has been selected and said device hasbeen programmed.
 53. The method according to claim 45, wherein said step(f) is executed by activating an event switch after a dose of medicationhas been taken so as to cause said device to display a time at which anext dose of said medication is to be taken.
 54. The method according toclaim 46, wherein said steps (a)-(i) are executed by activating an inputdevice which communicates with said prescription compliance device. 55.The method according to claim 54, wherein said input device communicateswith said prescription compliance device via a wireless link.
 56. Themethod according to claim 55, wherein said wireless link is an infraredlink.
 57. The method according to claim 55, further comprising the stepof recording times at which doses of medication are taken when saidevent switch is activated.
 58. The method according to claim 56, furthercomprising the step of accessing the recorded times via said wirelesslink.
 59. A prescription compliance device comprising:microcontroller; aprogram memory storing data representing a plurality of pre-programmedmedication-taking regimens; a selector selecting one of said regimensand programming said device in accordance therewith; a display; an alarmcircuit alerting a patient at times when said patient is scheduled totake a dose of medication, wherein said selector includes an eventswitch which is activated by said patient after taking a dose of saidmedication to record the taking of said medication, said event switchcausing said microcontroller to effect the display of the time at whicha next dose of said medication is scheduled to be taken, in accordancewith the regimen selected by said selector, and wherein said alarmcircuit is activated if said patient takes a dose of said medication andpresses said event switch more than a predetermined time before or aftera time at which a next dose is scheduled to be taken.
 60. A prescriptioncompliance device comprising:control means; program memory means forstoring data representing a plurality of pre-programmedmedication-taking regimens; select means for selecting one of saidregimens and programming said device in accordance therewith; displaymeans; alarm means for alerting a patient at times when said patient isscheduled to take a dose of said medication, wherein said select meansincludes an event switch which is activated by said patient after takinga dose of said medication for recording the taking of said medication,said event switch causing said control means to effect the display ofthe time at which a next dose of said medication is scheduled to betaken, in accordance with the regimen selected by said select means, andwherein said alarm means is activated if said patient takes a dose ofsaid medication and presses said event switch more than a predeterminedtime before or after a time at which a next dose is scheduled to betaken.
 61. A prescription compliance system, comprising:a prescriptioncompliance device configured to indicate when a prescription is to beadministered; a patient identifying device configured to identify apatient taking the prescription; and a recorder configured to recordreceived signals from the prescription compliance device and the patientidentifying device, wherein the prescription compliance device transmitsa signal directly or indirectly to the patient identifying device andthe recorder when the prescription is to be taken or has been taken, thepatient identifying device transmits a patient identification signal tothe recorder when the patient has taken the prescription, and therecorder records the signals transmitted by the prescription compliancedevice and the patient identifying device so as to confirm that theprescription was taken by the identified patient.
 62. The systemaccording to claim 61, wherein a location of the recorder is identifiedallowing correlation of the prescription-taking event with the patientand the location.
 63. A prescription compliance system,comprising:prescription compliance means for indicating when aprescription is to be administered; patient identifying means foridentifying a patient taking the prescription; and recorder means forrecording received signals from the prescription compliance means andthe patient identifying means, wherein the prescription compliance meanstransmits a signal directly or indirectly to the patient identifyingmeans and the recorder means when the prescription is to be taken or hasbeen taken, the patient identifying means transmits a patientidentification signal to the recorder means when the patient has takenthe prescription, and the recorder means records the signals transmittedby the prescription compliance means and the patient identifying meansso as to confirm that the prescription was taken by the identifiedpatient.
 64. The system according to claim 63, wherein a location of therecorder is identified allowing correlation of the prescription-takingevent with the patient and the location.
 65. A prescription compliancemethod, comprising the steps of:transmitting, by a prescriptioncompliance device, a signal directly or indirectly to a patientidentifying device and a recorder when a prescription is to beadministered or has been administered; transmitting a patientidentification signal to the recorder when the patient has taken theprescription; recording the signals transmitted by the prescriptioncompliance device and the patient identifying device; and confirmingthat the prescription was taken by the identified patient by correlatingthe recorded signals.
 66. The method according to claim 65, furthercomprising the steps of:identifying a location of the recorder; andcorrelating the prescription-taking event with the patient and thelocation.
 67. The device according to claim 1, wherein said display isconfigured to identify the medication corresponding to the respectivemedication-taking regimen.
 68. The device according to claim 26, whereinsaid display means identifies the medication corresponding to therespective medication-taking regimen.
 69. The method according to claim45, wherein the prescription compliance device includes a displayconfigured to identify the medication.
 70. The method according to claim46, wherein said steps (a) and (i) are executed by activating a resetbutton.